The delivery system requires a prescribed volume for THV deployment and proper function (11 mL, 17 mL, 23 mL, 33 mL). When deploying the valve, inflate the balloon slowly and continuously throughout deployment. In the Urgent Field Safety Notice to customers, Edwards provided the following recommendations and instructions for physicians: 23, 2018 and Jthe devices would have been involved in procedures starting Jan. The recall affects all lot numbers manufactured between Jan. The Sapien 3 is indicated for use in patients with severe, symptomatic, aortic valve stenosis, a narrowing of the heart’s aortic valve that restricts blood flow to aorta, the body’s main artery. It is used to deliver and deploy the Edwards Sapien 3 Ultra or the Edwards Sapien 3 transcatheter heart valve to replace a diseased aortic valve without open-heart surgery. The Edwards Sapien 3 Ultra delivery system is a part of the Edwards Sapien 3 transcatheter heart valve system.
Seventeen injuries and one death were reported at the time when Edwards initiated the Field Corrective Action in July 2019. The company said this may cause vascular injury, bleeding or surgical intervention. AugEdwards Lifesciences is recalling the Sapien 3 Ultra delivery system after receiving reports of burst balloons during implantation procedures, which have resulted in significant difficulty retrieving the valve into the catheter and withdrawing the system from the patient.
0 kommentar(er)
